Computer System Support Specialist

5 days ago

Hillsboro OR USA, United States TalentBurst Full time
Job Description

TalentBurst is seeking a highly skilled Computer System Support Specialist to join our team. As a key member of our IT OT organization, you will play a critical role in supporting the daily operations of our manufacturing IT systems.

Key Responsibilities
  • Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and support the team in manufacturing site projects and with various administrative tasks and validation activities.
  • Work to support the ITOT System owners in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testing.
  • Update System lifecycle documentation, as the need arises, for ITOT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT).
  • Help perform MILE (system maintenance) activities for ITOT Systems.
  • Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year's worth of planned and unplanned events, reviewing the impact on the system's validated state and drafting reports.
  • Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect ITOT Systems.
  • Support System Owner Squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
  • Support validation activities, generation, approval and execution of validation protocols.
  • Assist System Owners in the Periodic System Audit Trail Review.
  • User account auditing, provisioning, resets and activation for all IT and OT systems.
  • Creating reports for various systems on demand.
  • Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
  • Review ServiceNow tickets and either address them or route them to the SME.
  • Support on document management systems (Veeva, Condor, eVal Roche).
  • Support the team with administrative tasks.
Requirements
  • Minimum Bachelor's degree in Computer Engineering, Automation Engineering or similar.
  • Minimum 5 years of experience in system and/or network administration.
Preferred Skills
  • System Administration.
  • Network Administration.
  • Experience with industrial data and control interfaces, preferably OPC and OPC-UA.
  • System administration, supporting multiple platforms and applications.
  • Ability create and execute validation on computerized systems.
  • Biopharmaceutical or similar Manufacturing domain knowledge.
  • Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.
  • Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
  • Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
  • Entrepreneurial mindset e.g. automating automation.

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